Medtronic Navigation, Inc.-Littleton

FDA Regulatory Profile

Summary

Total Recalls
20
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2026-2024Class IIO-arm O2 Imaging System-Mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult anApril 26, 2024
Z-2449-2023Class IIThe O-arm O2 Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging forJuly 25, 2023
Z-0767-2020Class IIO-arm" O2 Imaging System, Product Number/CFN: BI-700-02000November 15, 2019
Z-1932-2019Class IIMedtronic 0-arm TM 1000 Imaging Systems: Bl-700-00027-XXX and B1-700-00028-XXX (where XXX indicates May 1, 2019
Z-0404-2019Class IIMedtronic Navigation 0-arm 02 Imaging System interventional fluoroscopic x-ray system: OARM BI700September 17, 2018
Z-0275-2019Class IIO-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027120 SYSTEM 120V, Model Number Bl700000271August 30, 2018
Z-0272-2019Class IIO-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027R SYS PRODUCT RWK, Model Number Bl7000002August 30, 2018
Z-0278-2019Class IIO-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027230R SYSTEM 230V RWK, Model Number Bl7000August 30, 2018
Z-0277-2019Class IIO-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027230 SYSTEM 230V, Model Number Bl7000002 7August 30, 2018
Z-0279-2019Class IIO-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027GER SYS PRODUCT GER, Model Number Bl70000August 30, 2018
Z-0274-2019Class IIO-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027100R SYSTEM lOOV RWK, Model Number Bl7000August 30, 2018
Z-0273-2019Class IIO-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027100 SYSTEM lOOV, Model Number Bl700000271August 30, 2018
Z-0271-2019Class IIO-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027 SYSTEM PRODUCT, Model Number Bl70000027 August 30, 2018
Z-0280-2019Class IIO-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027GERR SYS PRODUCT REFURB, Model Number Bl7August 30, 2018
Z-0276-2019Class IIO-arm 1000 2nd Edition Imaging System, BASE BASE OARM Bl70000027120R SYSTEM 120V RWK, Model Number BAugust 30, 2018
Z-0928-2018Class IIO-arm 1000 mobile image-intensified fluoroscopic x-ray system; (1) Model: BASE OARM Bl70000028100 SYJanuary 25, 2018
Z-0927-2018Class IIO-arm¿ O2 interventional fluoroscopic x-ray system; Catalog Number: B1-700-02000 The O-arm O2 ImaSeptember 30, 2017
Z-0070-2017Class IIMedtronic Navigation O-arm O2 Surgical Imaging System Product Catalog Number: BI-700-02000 ProducSeptember 22, 2016
Z-2082-2016Class IIMedtronic 0-arm Imaging mobile x-ray system. Model Numbers - B1-700-00027, B1-700-00028March 17, 2016
Z-2083-2016Class IIMedtronic Navigation O-arm 02 surgical x-ray imaging systemMarch 17, 2016